NCT02632227

Brief Summary

The purpose of this study was to evaluate the clinical usefulness of TFU (transfontanel ultrasound)for the prediction of fluid responsiveness in children undergoing congenital heart surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2015

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

April 5, 2018

Status Verified

April 1, 2018

Enrollment Period

1.2 years

First QC Date

December 13, 2015

Last Update Submit

April 4, 2018

Conditions

Fluid Responsiveness

Outcome Measures

Primary Outcomes (1)

  • change in respiratory variation of carotid artery blood flow peak velocity after volume expansion

    before and after fluid administration (20min)

Secondary Outcomes (3)

  • change in cardiac index after volume expansion

    before and after fluid administration (20min)

  • change in pleth variability index after volume expansion

    before and after fluid administration (20min)

  • change in respiratory variation of aorta flow blood flow peak velocity after volume expansion

    before and after fluid administration (20min)

Study Arms (1)

Hypovolemia

patients with hypovolemic signs including hypotension, decreased central venous pressure (less than 5mmHg), and decreased urine output

Procedure: TFU(transfontanel ultrasound)

Interventions

TFU(transfontanel ultrasound)PROCEDURE

The respiratory variation of the carotid artery blood flow peak velocity was measured using TFU before and after the fluid administration (10ml/kg for 20 min.)

Hypovolemia

Eligibility Criteria

AgeUp to 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

pediatric patients with congenital heart disease undergoing cardiac surgery

You may qualify if:

  • pediatric patients undergoing cardiac surgery

You may not qualify if:

  • preterm closure of anterior fontanelle
  • anatomical abnormalities on aortic arch (ex, patent ductus arteriosus)
  • presence of intracardiac and extracardiac shunt

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul national university hospital

Seoul, South Korea

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 13, 2015

First Posted

December 16, 2015

Study Start

December 1, 2015

Primary Completion

March 1, 2017

Study Completion

October 1, 2017

Last Updated

April 5, 2018

Record last verified: 2018-04

Locations

KR(1)